LXM — Manipulator, Plunger-Like Joint Class U

FDA Device Classification

FDA product code LXM covers "Manipulator, Plunger-Like Joint", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LXM
Device Class
Class U
Regulation Number
Submission Type
Review Panel
PM
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K234036Neuro Spinal InnovationSONIK MONARK 100Feb 15, 2024
K192629Optima Health Solutions InternationalSpinalyticsDec 21, 2019
K172536SpinalightAtlas Percussion Adjusting InstrumentJun 20, 2018
K160278Spinal AcousticsVSTAAR AdjusteRNov 4, 2016
K130666Optima Health Solutions International CorporationKHAN KINETIC TREATMENT (KKT-M2)Jan 23, 2014
K112606Activator Methods InternationalACTIVATOR V-EMar 6, 2012
K082218Manna Omni InternationalMAX ADJUSTING INSTRUMENTAug 13, 2008
K080261Neuromechanical InnovationsIMPULSE IQ ADJUSTING INSTRUMENTApr 11, 2008
K072519Activator Methods InternationalACTIVATOR V SPINAL ADJUSTING INSTRUMENTOct 23, 2007
K060043Optima Health Solutions InternationalKHAN KINETIC TREATMENT DEVICE (KKT-M1)Mar 23, 2006
K050428Advanced Spinal TechnologiesTECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)Jun 14, 2005
K023462Neuromechanical InnovationsIMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTINJan 13, 2003
K021238Frye Health SystemsFRYE ADJUSTING INSTRUMENTOct 9, 2002
K010851Harrison Cbp SeminarsHARRISON HAND HELD ADJUSTING INSTRUMENTSep 18, 2001
K003185Activator Methods InternationalFS ACTIVATOR IIIMar 20, 2001
K001476SpinalightTORQUE INSTRUMENT, MODEL 8500Aug 4, 2000
K973914Sense TechnologySENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTARJun 30, 1998
K974376J-Tech MedicalJTECH ADJUSTER REFLEX GUNFeb 18, 1998
K973506Activator MethodsACTIVATOR IIJan 27, 1998
K962239SigmaSMART ADJUSTER (SA201)Jan 10, 1997